STERILE WATER FOR INHALATION FLEX BAG, USP

K090915 · Cardinal Health, Inc. · BTT · Nov 18, 2009 · Anesthesiology

Device Facts

• Record ID: K090915
• Device Name: STERILE WATER FOR INHALATION FLEX BAG, USP
• Applicant: Cardinal Health, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Nov 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Sterile Water for Inhalation Flex Bag USP bag is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers It is intended to be used in institutional and non institutional care settings

Device Story

Device consists of flexible plastic bag pre-filled with sterile water; includes single port at base. Tubular feed sets connect bag to unfilled humidifier chambers. Water flows via gravity to fill humidifier chambers. Used in institutional and non-institutional care settings. Provides sterile water supply for respiratory humidification systems.

Clinical Evidence

No clinical data. Verification and validation testing demonstrated the device meets performance requirements.

Technological Characteristics

Flexible plastic bag with single port; gravity-fed delivery system. Sterile water for inhalation USP. Disposable container.

Indications for Use

Indicated for providing sterile water to unfilled respiratory humidifier chambers in institutional and non-institutional care settings.

Regulatory Classification

Identification

A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

Predicate Devices

• Respiratory Therapy Solutions - Flexible (K780381)
• Prefilled Respiratory Therapy Humidifier containing Sterile Water for Inhalation USP (K853146)
• U Mid Prefilled Humidifier Becton Dickinson Vacutainer Systems Pre-Analytic (K760584)

Submission Summary (Full Text)

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K090915

## 510 (K) SUMMARY

NOV 1 g 2009

| . Manufacturer | Cardinal Health<br>1500 Waukegan Road<br>McGaw Park Illinois 60085 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kimberly Southwell<br>760-778-7280 (phone/fax) |
| Summary Date | March 18 2009 |
| Device Trade Name | Sterile Water for Inhalation Flex Bag USP |
| Device Common/<br>Classification Name | Humidifier Respiratory Gas / Sterile Water for<br>Inhalation |
| Regulation Number | 868 5450 |
| Product Code | BTT |
| Device Class | Class II |
| Classification Panel | Anesthesiology |
| Predicate Device | The predicate device(s) are |
| | K780381 Respiratory Therapy Solutions - Flexible |
| | K853146 Prefilled Respiratory Therapy Humidifier<br>containing Sterile Water for Inhalation USP |
| | K760584 U Mid Prefilled Humidifier Becton<br>Dickinson Vacutainer Systems Pre-Analytic |
| Device Description | The Sterile Water for Inhalation Flex Bag USP is a<br>flexible plastic bag with a single port at the base<br>and is pre-filled with sterile water |
| | Tubular feed sets connect the sterile water bags to<br>unfilled humidifier chambers |
| | The humidifier chamber is then filled with sterile<br>water from the sterile water bags via gravity |

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## Intended Use

The Stenle Water for Inhalation Flex Bag USP bag is intended to provide a supply of stenle water to unfilled respiratory humidifier chambers It is intended to be used in institutional and non institutional care settings

#### Substantial equivalence

The Sterile Water for Inhalation Flex Bag USP bag is comparable to the predicate devices in so far as it is a supply of stenle water for inhalation and is used in conjunction with a humidification system

The Cardinal Health Sterile Water for Inhalation Flex Bag has the following similanties to those which previously received 510(k) concurrence

the same basic intended use (supply of stenle water for inhalation)

BTT Classification

manufactured and packaged utilizing same basic processes (stenle water for inhalation USP in a disposable plastic container)

sterile water end use is in conjunction with humidification systems

The Cardinal Health Stenle Water for Inhalation Flex Bag described in this submission is in our opinion is substantially equivalent to the predicate device(s) disclosed

#### Summary of Testing Verification and Validatıon

Venfication and Validation Testing demonstrates that the Cardinal Health Sterile Water for Inhalation Flex Bag meets its intended performance requirements at all levels and that this device is substantially equivalent to medical devices currently legally marketed in the United States

Response to 30 Party Findings

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062-2096

NOV 1 8 2009

Re: K090915

Trade/Device Name: Sterile Water for Inhalation Flex Bag USP Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: November 6, 2009 Received: November 9, 2009

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2- Mr. Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K090915

Device Name Sterile Water for Inhalation Flex Bag USP

Indications for Use

The Sterile Water for Inhalation Flex Bag USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers It is intended to be used In institutional and non institutional care settings

Prescription Use XX Over The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE OF NEEDED

L. Smith
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

) Number: K090915

Response to 30 Party Findings

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